F.D.A. Lets Others Inspect Plants Again

By MELODY PETERSEN

Published: April 3, 2002

Even if government inspectors have found widespread problems in pharmaceutical factories, the Food and Drug Administration sometimes approves new medicines to be made in those factories without inspecting them again, relying on company employees or consultants to verify that the problems have been fixed, the agency said yesterday.

The practice came to light yesterday after a trade journal called Dickinson's FDA Webview reported that the F.D.A. had approved Clarinex, the new allergy drug made by Schering-Plough, based on factory inspections done by consultants hired by the company rather than by the government.

David J. Horowitz, acting director of the office of compliance in the F.D.A.'s Center for Drug Evaluation, refused to discuss the agency's dealings with Schering-Plough or the approval of Clarinex. But he did say the agency sometimes relied on reports by a company's employees or consultants to determine whether manufacturing problems previously identified by the agency had been fully addressed.

''It is the substance and persuasiveness of the information submitted,'' Mr. Horowitz said, that determines whether the agency accepts a company's report rather than sending an inspector back to the factory. He said the F.D.A. was limited in the number of inspections it could undertake because of its budget.

''Limited resources require us to make choices every day,'' he said.

Schering-Plough said yesterday that the F.D.A. knew the company was using Lachman Consultant Services to evaluate its factories and had approved of the procedures used by the consultant. Lachman did not return repeated telephone calls yesterday.

Schering-Plough told investors early last year that the F.D.A. was withholding approval of Clarinex because of problems that government inspectors had found in its factories. According to federal inspection reports, the widespread problems, which dated back to 1998, involved three of the company's factories and more than a dozen medicines.

The report on Schering's efforts to win approval of Clarinex, which was published Monday, was based in part on reporting by John Scharmann, a former director in the F.D.A.'s Denver office who now writes articles for Dickinson's FDA Webview.

The Dickinson article said that the F.D.A.'s Office of Criminal Investigation was looking into how Schering-Plough had hired Lachman to write a report on whether it was complying with federal manufacturing rules at its factory in Las Piedras, P.R., where Clarinex is made, and then had used Lachman's findings to gain F.D.A. approval of the drug. The article said that at the same time Lachman was undertaking what it called a compliance audit, the company was also providing consulting services to Schering-Plough, resulting in a conflict of interest.

Brad Stone, a spokesman for the F.D.A., said the agency could not discuss whether an investigation might be taking place.

Schering-Plough said yesterday in a statement rejected as ''baseless'' that the article's suggestion that the Lachman consultants had a conflict of interest when they prepared the report for the company.

The company said the report that Lachman prepared was part of Schering-Plough's negotiations with the F.D.A. to reach an agreement, known as a consent decree, that would resolve its longstanding manufacturing problems.

Late last year, Schering-Plough said it might have to pay as much as $500 million to the government as part of that agreement.

Mr. Stone said F.D.A. inspectors had not been back to the Las Piedras factory since last year, when two lengthy government inspections took place, the first for more than two weeks in February and the second from May 1 to June 6.

At the end of that last inspection, F.D.A. officials wrote a report that said the company had not yet fixed some of the problems found in previous government inspections. According to that six-page report, the government's inspector found that in some cases the company was not properly investigating possible problems identified by quality tests performed during the manufacturing process.